Restorelle 501520Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05708932528108), received between Jul 27, 2021 and Jan 20, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED PELVIC AND ABDOMINAL PAIN, LOWER BACK PAIN, EXTRUSION, PROTRUSION, URINARY ISSUES, RECURRENCE, STRESS URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL CRAMPING, NOCTURIA, SUPRAPUBIC PRESSURE, PAIN, PERMANENT DISFIGUREMENT, AND DIFFICULTY WITH DAILY ACTIVITIES WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH ON (B)(6) 2024.

  Patient problems: Abnormal Vaginal Discharge; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Fecal Incontinence; Inflammation; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 24115896 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A RESTORELLE IMPLANTED IN (B)(6) 2024. REPORTEDLY THE PATIENT EXPERIENCED RIGHT HIP, BACK, AND BUTTOCK PAIN. IN (B)(6) 2025, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED FOR INFECTION OF SACROCOLPOPEXY MESH (RESTORELLE Y) AT ATTACHMENT ANTERIOR L5-S1 WITH SECONDARY DISCITIS-OSTEOMYELITIS. PATIENT UNDERWENT ROBOTIC ASSISTED MESH EXCISION AND DRAINAGE OF RETROPERITONEAL COLLECTION UNDER GENERAL ANESTHESIA. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON IV ANTIBIOTICS. PATIENT READMITTED FOR CONTINUED BACK PAIN. RECEIVED PAIN MEDICATION AND MUSCLE RELAXERS AND ULTIMATELY UNDERWENT L4-L5 POSTERIOR ARTHRODESIS, L5-S1 POSTERIOR ARTHRODESIS, SEGMENTAL INSTRUMENTATION L4-S1 USING ALPHATEC INVICTUS, ATTACHMENT OF CAUDAL INSTRUMENTATION TO THE PELVIS USING S2 AI SCREWS ALPHATEC AND USE OF LOCAL AUTOGRAFT AND ALLOGRAFT SUPPLEMENTED WITH BMP UNDER GENERAL ANESTHESIA.

  Patient problems: Osteomyelitis; Pain; Unspecified Infection

  MAUDE report 24108935 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED PROTRUSION OF THE MESH, EXTRUSION, EXCISION, BLEEDING, INFECTIONS, PELVIC FLOOR DISFUNCTION, PELVIC PAIN, VAGINAL PAIN, DYSPAREUNIA, URINARY URGENCY PROBLEMS, SCARRING, DIFFICULTY WITH DAILY ACTIVITIES, AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Kidney Infection; Micturition Urgency; Nervous System Injury; Pain; Pelvic Pain; Scar Tissue; Unspecified Infection; Urinary Retention

  MAUDE report 22341630 ↗
• InjuryJun 20, 2025Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT UNDERWENT A HYSTERECTOMY AND ROBOTIC SACROCOLPOPEXY SUCCESSFULLY WITH RESTORELLE. APPROXIMATELY 7 WEEKS POST OP, THE PATIENT FELT A "POP" AND SUBSEQUENTLY LOST THE VAGINAL APICAL SUPPORT SHE'D HAD POST SURGERY. A REVISION SURGERY WAS PERFORMED AND UPON INSPECTION THE RESTORELLE Y CONTOUR WAS NO LONGER HOLDING UP THE VAGINAL CUFF TO THE SACRAL PROMONTORY AND APPEARED TO BE DISCONNECTED SOMEWHERE BETWEEN THE SACRUM AND THE VAGINAL APEX. MESH AND SUTURES COULD BE SEEN AT THE PROMONTORY AND THE POSTERIOR ASPECT OF THE VAGINA UP TO THE VAGINAL CUFF. NO MESH WAS SEEN ON THE ANTERIOR VAGINAL WELL BUT THAT COULD HAVE BEEN THE DISSECTION PLANE USED BY THE SURGEON ON THE ANTERIOR SIDE. THE MESH POSTERIORLY WAS WELL INCORPORATED INTO HEALTHY VAGINAL TISSUE AND ONLY APPROXIMATELY ½ OF THE MESH WAS DISSECTED OUT. A NEW RESTORELLE MESH WAS IMPLANTED IN THE PATIENT SUCCESSFULLY. THE POSTERIOR ARM WAS IMPLANTED OVER THE PREVIOUSLY IMPLANTED AND INCORPORATED POSTERIOR ARM WHILE THE ANTERIOR ARM WAS SEWN ON WITH INDIVIDUAL SUTURES AND PULLED UP TO THE SACRUM IN THE NORMAL MANNER AND FIXATED WITH 2 PERMANENT "PROLENE" SUTURES.

  Patient problems: Prolapse

  MAUDE report 22299530 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED NAUSEA, VOMITING, ACUTE KIDNEY INJURY, SMALL BOWEL OBSTRUCTION CAUSED BY MESH ADHESION TO UTERINE AND SMALL BOWEL, ACUTE RENAL FAILURE WITH TUBULAR NECROSIS DUE TO POST-OP SMALL BOWEL OBSTRUCTION, SIGNIFICANT BILE EFFLUENT FROM NG "[NASOGASTRIC]", HIGH OUTPUT FROM NG, HYPOKALEMIA AND HYPOPHOSPHATEMIA. LAPAROSCOPIC REMOVAL OF MESH WAS PERFORMED.

  Patient problems: Abnormal scarring; Adhesion(s); Biliary Leak; Deformity/ Disfigurement; Dyspareunia; Electrolyte Imbalance; Emotional Changes; Erosion; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hypokalemia; Nausea; Necrosis; Obstruction/Occlusion; Pain; Pelvic Pain; Renal Failure; Unspecified Infection; Urinary Incontinence; Vomiting

  MAUDE report 22285492 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A SUPRIS SLING AND A RESTORELLE MESH IMPLANTED. REPORTEDLY, THE PATIENT EXPERIENCED MESH EXPOSURE AND EXCISION OF VAGINAL MESH UNDER GENERAL ANESTHESIA.

  Patient problems: Erosion

  MAUDE report 21763125 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED ABDOMINAL PAIN, BLADDER SPASMS, FEELING OF INCOMPLETE EMPTYING OF HER BOWELS, CONSTIPATION, PELVIC PAIN, FLUID COLLECTION AT THE SITE OF HER MESH WITH CONCERN FOR INFECTION (NOTED ON MRI), PAIN WITH DEFECATION, PELVIC FLOOR DYSFUNCTION, URINARY TRACT INFECTION, BLADDER PAIN, VAGINAL DISCHARGE, TRIGONITIS, MIXED STRESS AND URGE URINARY INCONTINENCE, URINARY FREQUENCY, URGENCY OF URINATION, NOCTURIA, BLADDER STONE AND MESH EROSION INTO THE BLADDER. THIS RESULTED IN ROBOTIC-ASSISTED LYSIS OF ADHESIONS WITH MESH EXPLORATION AND CYSTOSCOPY UNDER GENERAL ANESTHESIA AND ULTIMATE MESH REMOVAL AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. POST EXCISION CYSTOSCOPY NOTES SLIGHT TRIGONITIS WITHOUT MESH EROSION AND WELL HEALING INCISION.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Cramp(s) /Muscle Spasm(s); Erosion; Inflammation; Micturition Urgency; Pain; Pelvic Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection; Urolithiasis

  MAUDE report 21363830 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, THE PATIENT HAD A RESTORELLE SLING IMPLANTED IN (B)(6) 2018. IN (B)(6) 2022, THE PATIENT EXPERIENCED EXPOSED VAGINAL MESH AT THE APEX AND VAGINAL BLEEDING RESULTING IN TRANSVAGINAL EXCISION OF THE MESH.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20461727 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED. THE PATIENT HAD A RESTORELLE MESH IMPLANTED ON (B)(6) 2019. FROM 2021, THE PATIENT REPORTEDLY HAD URINARY FREQUENCY, INCONTINENCE, EXPOSURE/ EROSION OF VAGINAL MESH, FEVER, PAIN, URINARY TRACT INFECTIONS, MUSCLE WEAKNESS, PROLAPSE AND BLEEDING. CYSTOSCOPY, BLADDER STONE/ FOREIGN BODY LASERING, RECTUS HARVEST, SLING EXCISION AND DRAINAGE OF ABDOMINAL WALL FLUID WERE PERFORMED.

  Patient problems: Erosion; Fever; Hemorrhage/Blood Loss/Bleeding; Muscle Weakness/Atrophy; Pain; Prolapse; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 20377174 ↗
• InjuryAug 23, 2024Material Deformation; Material Deformation

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED THE PATIENT WAS IMPLANTED WITH RESTORELLE Y. THE DEVICE FAILED, HAVING ERODED INTO THE VAGINAL WALL. PATIENT UNDERWENT SUBSEQUENT SURGERY TO REMOVE THE DEVICE ON (B)(6) 2023. THE MESH HAD FOLDED OVER ON ITSELF AND FORMED A WAD. REMOVING THE MESH REQUIRED THE SURGEON TO ALSO REMOVE PATIENT'S RIGHT FALLOPIAN TUBE AND RIGHT OVARY. PATIENT SUFFERED A COMPLETE ANTERIOR VAGINAL PROLAPSE DUE TO MESH REMOVAL SURGERY. ON (B)(6) 2023, PATIENT UNDERWENT ANOTHER SURGERY TO CORRECT THE VAGINAL PROLAPSE.

  Patient problems: Deformity/ Disfigurement; Erosion; Pain; Prolapse

  MAUDE report 20055335 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 2/27/2024 INDICATED THAT THE PATIENT WAS ALSO EXPERIENCING A BROWN TINGED DISCHARGE.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Intermenstrual Bleeding

  MAUDE report 18894854 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DISCHARGE, BLEEDING, DYSPAREUNIA, EROSION, EXPOSURE, HEMATURIA, PAIN, URINARY URGENCY, URINARY FREQUENCY, URINARY INCONTINENCE, NEURALGIA, ANXIETY AND SURGERY TO REMOVE THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Anxiety; Dyspareunia; Erosion; Hematuria; Intermenstrual Bleeding; Interstitial Cystitis; Micturition Urgency; Neuralgia; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 18812987 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DISCHARGE, BLEEDING, CONSTIPATION, INFECTION, INFLAMMATION, PAIN, URINARY INCONTINENCE AND SURGERY TO REMOVE THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Inflammation; Intermenstrual Bleeding; Pain; Unspecified Infection; Urinary Incontinence

  MAUDE report 18713797 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATES THE PATIENT WITH THIS DEVICE EXPERIENCED URINARY FREQUENCY, URINARY INCONTINENCE, EXPOSURE OF IMPLANTED VAGINAL DEVICE, STRESS INCONTINENCE, EROSION OF VAGINAL DEVICE, AND A CT GUIDED DRAIN PLACEMENT INTO LOWER ABDOMINAL WALL FLUID COLLECTION USING CONSCIOUS SEDATION. PATIENT HAD CYSTOSCOPY, LASER OF BLADDER STONE AND FOREIGN BODY, AND RECTUS HARVEST UNDER GENERAL ANESTHESIA. PATIENT ALSO HAD A ROBOTIC ASSISTED LAPAROSCOPIC EXCISION OF MID URETHRAL SLING AND THE DEVICE WITHIN BLADDER AND CLOSURE, CYSTOTOMY, RECTUS FASCIAL HARVEST AND PLACEMENT OF A RECTAL FASCIA URETHRAL DEVICE, AND CYSTOSCOPY UNDER GENERAL ANESTHESIA.

  Patient problems: Erosion; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 16870680 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED RECURRENT URINARY TRACT INFECTION, MILD DYSURIA, PELVIC PAIN, AND SHARP PAINS THROUGHOUT LEFT GROIN. PATIENT HAD ROBOTIC ASSISTED SACROCOLPOPEXY, IMPLANT OF GRAFT, PARAVAGINAL REPAIR, REVISION OF THE DEVICE, RELEASE OF PRIOR DEVICE FROM ANOTHER MANUFACTURER, CYSTOSCOPY, AND DISCHARGE WITH A CATHETER. INTRAOPERATIVE FINDINGS NOTED NO EROSION OF DEVICE INTO VAGINA, SUBURETHRAL THE VAGINA SUPPORTED WITH PROLAPSE BEHIND IT. PRIOR DEVICE IN PLACE AND INTACT FROM THE SACRUM TO THE VAGINA.

  Patient problems: Dysuria; Hematuria; Pain; Urinary Tract Infection

  MAUDE report 16782140 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DEVICE IMPLANTATION FOR RECURRENCE OF VAGINAL VAULT PROLAPSE AND THE PLACEMENT OF A RIGHT URETERAL STENT. DURING THE PROCEDURE, AN OLD UNKNOWN Y-MESH DEVICE WAS EXPLANTED IN ITS ENTIRETY. POST OPERATIVELY THE PATIENT HAD A FEVER AND ABDOMINAL PAIN. THE PATIENT WAS DIAGNOSED WITH A POSSIBLE URINARY TRACT INFECTION THAT REQUIRED ANTIBIOTICS FOR TREATMENT.

  Patient problems: Abdominal Pain; Fever; Urinary Tract Infection

  MAUDE report 16238560 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED COLOVAGINAL FISTULA AND INFECTED VAGINAL DEVICE.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 16154082 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED A SMALL BOWEL OBSTRUCTION WITH ISCHEMIA OF MID JEJUNUM, A LOOP OF SMALL INTESTINE MEASURING APPROXIMATELY 20 CM HERNIATED UNDER THE RIGHT-SIDED LIMB OF THE DEVICE WHICH WAS ATTACHED TO THE PRESACRAL REGION, URINARY RETENTION, RECURRENT CYSTOCELE, HEMATURIA, AND URETHRAL IRRITATION.

  Patient problems: Hematuria; Obstruction/Occlusion; Prolapse; Urinary Retention

  MAUDE report 16142180 ↗
• InjurySep 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE LEGAL REPRESENTATIVE STATED PATIENT HAD REVISION SURGERIES ON (B)(6) 2018 AND AGAIN ON (B)(6) 2019 DUE TO DEVICE ERODING INTO VAGINAL CANAL CAUSING INTENSE PELVIC PAIN AND RESULTING IN DORSAL ABRASION OF HER PARTNER FOLLOWING INTERCOURSE.

  Patient problems: Micturition Urgency; Pain; Skin Erosion

  MAUDE report 15471325 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED KIDNEY INFECTION, URINARY TRACT INFECTIONS, SEVERE PELVIC PAIN, URINARY URGENCY, INCONTINENCE, MENTAL ANGUISH, PHYSICAL DEFORMITY, EROSION OF VAGINAL AND OTHER TISSUES, LOSS OF ABILITY TO PERFORM SEXUALLY AND DIFFICULTY WITH DAILY ACTIVITIES. THE PATIENT HAD A REVISION OF THE DEVICE AND ANOTHER PROCEDURE TO ADDRESS HER KIDNEY STONES AND ACUTE CYSTITIS WITH HEMATURIA.

  Patient problems: Deformity/ Disfigurement; Emotional Changes; Erosion; Hematuria; Kidney Infection; Micturition Urgency; Pain; Sexual Dysfunction; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 15324657 ↗
• InjuryMay 20, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED EXPOSURE ALONG ANTERIOR VAGINAL WALL AND VAGINAL VAULT PROLAPSE. A ROBOTIC ASSISTED PROCEDURE WAS USED TO IMPLANT THE DEVICE FOR SACRAL COLPOPEXY WITH ANOTHER DEVICE COMPANY'S SUTURES, LYSIS OF ADHESIONS AND BILATERAL SALPINGO-OOPHORECTOMY. A ROBOT UNDOCKED PROCEDURE WAS USED FOR EXPLANTATION OF THE DEVICE DUE TO EXPOSURE AND CYSTOURETHROSCOPY. INTRAOPERATIVE FINDINGS INDICATED A FEW ADHESIONS OVER VAGINAL APEX, A FEW FILMY BOWEL ADHESIONS TO ANTERIOR ABDOMINAL WALL AND SIDE WALL (LYSED), THE BLADDER WAS NOTED TO BE DIFFICULT TO DISSECT OFF THE ANTERIOR VAGINAL WALL, AND A SLIGHTLY ENLARGED CYSTIC RIGHT OVARY WAS ALSO NOTED. AN INTRAOPERATIVE DECISION WAS MADE TO REMOVE BILATERAL TUBES AND OVARIES. AN ADDITIONAL PROCEDURE TO EXPLANT THE DEVICE DUE TO EXPOSURE WAS PERFORMED. INTRAOPERATIVE FINDINGS NOTED ALL VISIBLE AND PALPABLE DEVICE WERE REMOVED ALONG ANTERIOR VAGINAL WALL.

  Patient problems: Adhesion(s); Cyst(s); Prolapse

  MAUDE report 14459230 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AFTER THE PATIENT SUFFERED VAGINAL PAIN, BLADDER PAIN, RECTAL PAIN, BURNING INFLAMMATION, AND IRRITATION. THERE WERE TWO REVISIONS BEFORE THE DEVICE WAS COMPLETELY REMOVED ALONG WITH THE PATIENT'S CERVIX WHICH HAD BEEN ERODED THROUGH AS WELL. THE PATIENT INDICATED SHE SUFFERED SIGNIFICANT HARM PHYSICALLY, EMOTIONALLY, AND FINANCIALLY.

  Patient problems: Abnormal Vaginal Discharge; Burning Sensation; Constipation; Deformity/ Disfigurement; Discomfort; Dyspareunia; Emotional Changes; Erosion; Genital Bleeding; Inflammation; Micturition Urgency; Pain; Sexual Dysfunction; Unspecified Infection; Urinary Incontinence; Urinary Retention

  MAUDE report 13767208 ↗
• InjuryJan 27, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT UNDERWENT A HYSTERECTOMY TO TREAT UTEROVAGINAL PROLAPSE. SUBSEQUENTLY, THE PROLAPSE RECURRED AND THE PATIENT PRESENTED FOR REVISION SURGERY. AT THAT TIME, IT WAS DISCOVERED THAT THE "Y" ARM OF THE DEVICE WAS BROKEN IN HALF BETWEEN THE "V" AND THE TERMINAL END OF THE IMPLANT. A NEW DEVICE WAS USED TO REPAIR THE PATIENT. MEDWATCH FORM MW5105163.

  Patient problems: Prolapse

  MAUDE report 13369329 ↗
• InjuryAug 5, 2021Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THE PHYSICIAN REPORTED A TEAR IN A RESTORELLE Y CONTOUR. MESH TORE, BAD CERVIX CAME OUT. FECAL INCONTINENCE ALSO OCCURRED. THE PHYSICIAN DID A RE-DO BY BUTTRESSING UPSYLON TO MESH THAT REMAINED.

  Patient problems: Fecal Incontinence; Incompetent Cervix

  MAUDE report 12285441 ↗
• InjuryJul 27, 2021Stretched; Stretched

  ADDITIONAL INFORMATION RECEIVED ON 7/28/2021. (B)(6) 2018 - (B)(6) 2021: MILD VAGINAL ATROPHY, DYSURIA, FREQUENCY, SECOND- DEGREE CYSTOCELE, MODERATE. FEELS PROLAPSE IS RECURRING- DESCRIBES AS VAGINAL BULGING, MILD VAGINAL ATROPHY, THIRD -DEGREE CYSTOCELE, MODERATE. SUI OBSERVED DURING UDS, UTI, INCOMPLETE BLADDER EMPTYING, URGENCY OF URINATION, VAGINAL VAULT PROLAPSE AFTER HYSTERECTOMY, CYSTOCELE, MIDLINE, ACQUIRED VAGINAL ENTEROCELE, CERVICAL STUMP PROLAPSE, COMPLICATION OF IMPLANTED VAGINAL MESH, RECURRENCE OF BLADDER PROLAPSE. STAGE 3 VAGINAL VAULT/ CERVICAL STUMP RECURRENT PROLAPSE AFTER HYSTERECTOMY & SACROCOLPOPEXY, INCOMPLETE BLADDER EMPTYING, NEED TO SPLINT TO URINATE. URINARY INCONTINENCE WITHOUT SENSORY AWARENESS, AND CONSTIPATION.

  Patient problems: Discomfort; Pain; Prolapse; Scar Tissue

  MAUDE report 12230319 ↗